BraiNet

GUDID 00865305000199

Mvap Medical Supplies, Inc.

Electrode/transducer strap, single-use

• Primary Device ID: 00865305000199
• NIH Device Record Key: 240031db-18d7-4cf2-9e6b-9ac5d837ba87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BraiNet
• Version Model Number: 104
• Company DUNS: 966205726
• Company Name: Mvap Medical Supplies, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00865305000199 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K043009

FDA Product Code

• GXY: Electrode, Cutaneous

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-09
• Device Publish Date: 2023-03-01